Catalyft PL Expandable Interbody System
by Medtronic Sofamor Danek USA, Inc.
510(k) K210425
Catalyft PL Expandable Interbody System is a Class II device made by Medtronic Sofamor Danek USA, Inc., cleared under FDA 510(k) K210425 on 24 May 2021, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK210425 | Date24 May 2021 | StatusActive |
Official records
- FDA 510(k) database K210425
Recalls
-
- Ongoing Z-0580-2026
Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.
Timeline
- Cleared FDA 510(k) K210425
- Recall initiated FDA recalls Z-0580-2026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MAX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent